Clinical Trials /

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

NCT01975701

Description:

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Related Conditions:
  • Glioma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
  • Official Title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: CBGJ398X2201
  • NCT ID: NCT01975701

Conditions

  • Recurrent Glioblastoma or Other Glioma Subtypes

Interventions

DrugSynonymsArms
BGJ398BGJ398X

Purpose

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Detailed Description

      Patients were enrolled in two groups. Group 1 enrolled patients who are not candidates for
      surgery. Group 2 was planned to enroll patients who are surgical candidates. Patients from
      both groups were evaluated for tumor response and progression by MRI every 8 weeks until
      disease progression or discontinuation from study using RANO criteria.
    

Trial Arms

NameTypeDescriptionInterventions
BGJ398XExperimentalTo estimate anti-tumor efficacy of BGJ398
  • BGJ398

Eligibility Criteria

        Inclusion criteria:

          1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of
             diagnosis or prior relapse.

          2. Written documentation of local or central laboratory determination of amplification or
             translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1,
             FGFR2,or FGFR3

          3. RANO defined tumor progression by MRI in comparison to a prior scan

          4. Patients must have received prior external beam radiotherapy and temozolomide.

        Exclusion criteria:

          1. History of another primary malignancy

          2. Prior or current treatment with a FGFR inhibitor

          3. Neurological symptoms related to underlying disease requiring increasing doses of
             corticosteroids

          4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously
             on an EIAED, the patient must be off of it for at least two weeks prior to study
             treatment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:6 months
Safety Issue:
Description:To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:5 years
Safety Issue:
Description:To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator
Measure:Overall Survival
Time Frame:5 years
Safety Issue:
Description:To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival
Measure:Safety and Tolerability
Time Frame:5 years
Safety Issue:
Description:Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • BGJ398,
  • recurrent glioblastoma'
  • recurrent GBM,
  • FGFR,

Last Updated

December 4, 2019